BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM

    MDR report key: 22910120 · Received August 27, 2025

    Report

    Report Number
    3005875675-2025-00015
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    May 1, 2022
    Report Date
    August 27, 2025
    Manufacturer
    GYNESONICS
    Product Code
    KNF
    UDI-DI
    10817929020326
    PMA / PMN Number
    K211535
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF DEVICE MALFUNCTION DURING THE PROCEDURE AND THE SYSTEM FUNCTIONED AS EXPECTED. SUBMISSION OF THIS REPORT IS ASSOCIATED WITH THE RECENT ACQUISITION OF GYNESONICS BY HOLOGIC, INC. DURING THE INTEGRATION INTO HOLOGIC'S ADVERSE EVENT REPORTING SYSTEM AND PROCEDURES, A REVIEW OF HISTORICAL ADVERSE EVENTS WAS PERFORMED. AS A RESULT, THIS EVENT WAS IDENTIFIED AS BEING REPORTABLE ON (B)(6) 2025 AND IS BEING REPORTED RETROACTIVELY OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO WAS TREATED ON (B)(6) 2022, WAS DIAGNOSED WITH A 5-CM SYMPTOMATIC FIBROID ON MR (IUUS MEASUREMENT WAS ~7 CM); GYNESONICS MEDICAL DIRECTOR HAD BEEN CONTACTED BY PHYSICIAN IN EARLY JUNE REGARDING THE PATIENT'S FIBROID CONTINUING TO GROW. REVIEW OF THE CASE BY GYNESONICS MEDICAL DIRECTOR AND GYNESONICS CLINICAL DIRECTOR SUGGESTED INDEPENDENT AGREEMENT REGARDING APPROXIMATELY HOW MUCH OF THE FIBROID'S VOLUME WAS ABLATED (30%-40%), WHICH MIGHT EXPLAIN THE CONTINUED GROWTH DUE TO UNDERABLATION. THE PATIENT REMAINED SYMPTOMATIC AND UNDERWENT MYOMECTOMY, WHICH WAS CHALLENGING DUE TO THE LACK OF SURGICAL PLANES BETWEEN THE ABLATED FIBROID AND THE MYOMETRIUM. INITIAL HISTOPATHOLOGY SUGGESTED EITHER A STUMP TUMOR OR LEIOMYOSARCOMA (LMS) AND IT WAS SENT OUT FOR EXTERNAL REVIEW THAT CONFIRMED LMS. THE PATIENT WILL UNDERGO APPROPRIATE SURGICAL STAGING AND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419257 SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM ULTRASOUND-GUIDED INTRAUTERINE RADIO-FREQUENCY ABLATION SYSTEM KNF GYNESONICS SONATA2-110 10817929020326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| O